Prospective Multicenter Pilot Study to Evaluate the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- False negative rate of vacuum-assisted biopsy
研究概览
简要总结
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. New generation of treatments or combinations lead to a high rate of pathological complete responses (pCR) in patients with human epidermal growth factor receptor 2 positive (HER2) and triple negative tumours. Safe omission of surgery in patients who receive NAC and achieve radiologic complete response depends on the ability to accurately estimate pCR preoperatively.
If pathological complete response after NAC could be accurately assessed by VAB, surgery could be avoided. In the context of new treatments or combinations with an increased pCR rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.
详细描述
A total of 66 patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery. The primary endpoint of the study is the false negative rate of VAB procedure. This rate will be calculated by comparing the detection of invasive or in situ carcinoma on surgical specimen versus VAB samples. The secondary endpoints of the study are feasibility, VAB procedure technical complications and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years or older.
- •Written informed consent provided.
- •Triple negative or HER2-positive / ER-negative or HER2-positive / ER-positive breast tumours.
- •Patients eligible for breast conservation after NAC.
- •Patients with T2-T3 N0 invasive breast cancer initially treated by NAC to allow breast conservation, who have received a minimum of 6 cycles of adequate NAC +/- anti-HER
- •Clinical complete response after NAC.
- •Radiological (mammography, breast US, breast MRI) complete response after NAC.
- •Patients predicted to be node-negative at treatment initiation.
排除标准
- •Patient younger than 18 years old.
- •Pregnant or breastfeeding women.
- •Proven metastatic axillary or internal mammary chain lymph node involvement before NAC proven by biopsy or cytology.
- •Bilateral breast cancer.
- •Contraindication to MRI.
- •Contraindication to breast conservation
- •Patients with a BRCA mutation or other autosomal dominant high-penetrance genetic predisposition to breast cancer.
- •Patients with limitation of freedom or under guardianship
- •Inability for psychological reasons
- •Hypersensitivity to local anaesthesia
- •Initial imaging showing ACR6 micro calcifications and/or ACR6 non-mass enhancement associated to the index lesion
结局指标
主要结局
False negative rate of vacuum-assisted biopsy
时间窗: During the surgery
Absence of invasive and in-situ carcinoma on vacuum-assisted biopsy but presence of invasive or in-situ carcinoma on the surgical specimen.
次要结局
未报告次要终点